Multiple disposable intracutaneous injector package



March 3, 1964 A.- s. TAYLOR ETAL 3,123,212

' MULTIPLE DIsPosABLE INTRACUTANEOUS INJECTOR PACKAGE Filed June 14, 19Go United States .Patent This invention relates `to a package having a plurality vof single-use injectors for Aadministering Aintracutaneous injections .of a biologically-active substance in which a :pronged metal vplate is assembledto a plastic holder serving as a handle with -a plurality lo-such assemblies racked in acupped plate, which `has provisions for sterilization of the `assembled item, and the injectors themselves.

'Intracutaneous injectors are employed in vmedical practices tor a wide variety of purposes, including diagnostic, prophylactic and therapeutic uses. In the past, lluids, greases, ointments, powders, crystals, andthe like, con- --taining or-'composed -of allergens, which are materials capable of elioiting` an allergic reaction, as Well as Vaccima-virus type products which are materials capable of eliciting a vesiculopustular lesion, -as Well as toxins, anti-k rtoxins, -.toxoids, sera, andthe like, have been lplaced in or on abraded or scratched vskin areas, or have been pressed through the skin `surface by puncturing instruments. y

Itis desirable that `such materials, here classed as biologica-.be administered as rapidly and inexpensively -as possible. vIt .is valso desirable `that such biologics be linsuch form that they may be administered in large numbers by unskilled labor` under the supervision of a single physician. For. the treatment of epidemics, it mayy be necessary to vaccinate or treat thousands of persons with biologics in a minimum of time, and under unfavorable conditions, with a minimum of medical supervision.

The present multiple disposable 'intracutaneous injecztor package is designed so that the administration may 'bei accomplished in a minimum of time by persons hav- "ing a minimum skill to persons who 'may not ybe accustomed to medical treatment. Such groups include'mili- :tary forces,`native populations, victims in a disaster area or an epidemic area, or a potential epidemicfarea, vor 'the Ilike.

It `is desirable that the injectors be single-use devices. 'If the injector is discarded after a single use, resteriliza- :tion is not required, and the likelihood of the transmission of blood-borne diseases such as'homologousserum `hepatitissis minimized. In vallergytests, if the injector `is lused but once, there is no possibility of a 'carry-over from one test to the next Which'might interfere with the reliability of results.

Our inventionprovides .asthe finjector a single-use, -handled holder which may conveniently be of plastic and which? has -an injection plate at one end onwhich the biologic substance is placed, and which holder is stored in a sheet containing a series of cups and which may, with some biologics, be sterilized in place, thus permitting the economical use of such holders. Other advantages and details will appear from the following description in conjunction with the accompanying drawings in which:

FlGURE 1 shows the assembled device with some of the injectors removed.

FIGURE 2 is a bottom view of a single injector.

FlGURE 3 is a sectional view through a single injector, shown bottom end up.

FIGURE 4 shows the cupped retaining sheet.

A cupped sheet 11 is formed from a single sheet of 3,123,212 Patented Mar. 3, 1964 disposable Amaterial `'such as plastic by a deep drawing or molding operation. VFor example, a sheetv of thermoplastic vresin may be warmed sufiiciently to be readily deformable and aplurality of retaining cups 12 can be drawn therein to forma molded sheet 13. A thick sheet having cut-out cupsmay be used, but the molded'sheet uses less material. lPreferably, kthe retaining .cups are comparatively sh allow andy cylindrical having.' al righty circular-cross-section. Other sections can be used forithe cupif theholderhas a cooperating, matingshape. 'Conveniently, the cupped sheet, as shown-in FIGURE 4, is

formed Vinto segments of a 'convenientsize vFor instance,'five cups4 by tive CupsgiVingatOtal of twenty-five.

In each such cup, as shownin FIGURE l, is a holder 114. The holder may be Vof solid or'hollowed .material, preferably plastic. The hollow .15 in the holder reduces the weight and Vsaves material costs, butis not The yend of the injector plate y.18,later described, out ofcontact with the vbottom of? .thecup rForme'dinto the side of the-holder and the sheet con- 'tac'ting'face of the shoulder isa gas vent`17. This gas vent is a small groove to permit the access of ygases to and from the portion of the cup '12 which is otherwise sealed off by the holder and itsshoulder. Such gas vent 17 can be comparatively small, of the order of a couple of thousandths of an inch or larger. It is designed `to permit the interior of the cups to be evacuated and to permit a sterilizing gas, such as ethylene oxide, to penetrate into and come in contact with the contents ofthe cups after the holders are assembled inthe molde'dsheet.

At one end of the-molded sheetis -an injector plate 18 which is conveniently of a stainless metal, suc-h as stainless steel or a nickel alloy or plated metaL'which has a cut-out hole 19,. At' leastpart ofthe-metal cut out from the hole 19 isbent into prongs Z0. Conveniently, the prongs are bent in a multiple die-forming operation in which rst an'octagonal hole -is-fformed, and inwhich next ,the triangular segments, to cha-nge the Octagon to a square,are cut along two sides lfrom the metal plate 4and bent at approximately `a right angle thereto to form prongs 20. Preferably, the points 21 of thegprongs are in substantially the sameplane. The prongs are of such length as to insure the adequate. penetration of `a'biologic material through a thick-skinned patient and yet are rshort enough not'to damage lthe :tender 4s'kin ofyounger patients. A total length'fof from two yto '-iive millimeters :for humans, and from two :to ten millimeters for animals, 'is' normally preferred-the length of the prong being -rneas- Adjacent the points 'holder by plate :supporting arms Y23' which'extendfrom the :main body of :the holder and -have therein a groove 27. Conveniently, two plate supporting arms are used,

`which :are formed to hold a round injector plate adjacent the end of the holder. Plate retaining protuberances 24 formed adjacent the groove serve to retain the injector plate in position. The plate retaining protuberances are preferably small enough and flexible enough for the injector plates to be readily snapped into position by hand during assembly.

The end of the holder may have a holder retaining ridge 25 formed on the external surface to reduce the area in Contact with the retaining cups. The holder retaining ridge is suiiiciently ilexible to retain the holder and the cup even if there is a commercial variation in size relationships. Because the area in contact is small, the friction between the holder and the cup is compara- 3 tively slight. holder retaining ridge may not be necessary.

The tips of the prongs forming the points are dipped in a biologic liquid. The biologic may be stored on the points in liquid form or the liquid on the prongs may be frozen and the moisture evaporated therefrom. The holders are assembled by pressing them into the cups with the handle section 26 extending above the cupped sheet 11. If the biologic is one which is not deactivated by a sterilizing gas, the holders may be assembled in the cups in the sheets. Each sheet of cups may then be wrapped in a lm (eg, poiyethylene) permeable to a sterilizing gas, and a number of these wrapped sheets containing the cupped holders may be placed in a final carton. These packed, but unsealed, cartons may be placed in a vacuum chamber, evacuated, and then subjected to the effects of a sterilizing gas such as ethylene oxide or propylene oxide or a mixture of such sterilizing gases, with a suitable inert, re-preventing diluent such as carbon dioxide or a haloalkane. For example, a mixture containing 20 percent ethylene oxide and 80 percent carbon dioxide rnay be introduced into the vacuum chamber under a positive pressure of pounds per square inch. This gas contains 600 milligrams of ethylene oxide per liter and obtains contact with the biologic to be sterilized by penetrating the sheet wrapping and flowing through the gas lvents 17. After a 31/2 to 41/2 hour sterilization at 32 i2 C. and 40i10 percent relative humidity, the assembled cartons are flushed out with pyrogen-free air, and are covered; thus readying them for storage or shipment. Other sterilizing cycles may be used.

Such a sterilizing technique is suitable for materials used to determine sensitivity prior to the administration of prophylactic or therapeutic doses (e.g., tetanus toxoid, gas gangrene antitoxin) and for diagnostics (e.g., Old Tuberculin, lymphogranuloma venereum skin test antigen), and for allergen tests.

For biologics which would be damaged by a sterilizing gas, either radiation sterilization may be used or the molded sheets and the holders, including the plates, may be sterilized separately and the biologic applied to the prongs adjacent the points by sterile techniques.

In general, test or diagnostic biologics containing nonviable organisms may be sterilized with ethylene oxide or other sterilizing gas. Live virus products, such as vaccinia (smallpox vaccine), should be handled by sterile techniques, as the sterilizing gases inactivate such live viral products.

Modications of the invention within the scope of the appended claims are obvious to those skilled in the art.

We claim:

l. A multiple disposable intracntaneous package comprising: a retaining sheet, ya plurality of circular cylindrical cups formed therein, and in each of such cups, a. plastic holder of rounded coniiguration and substantially circular cross section adapted to iit in and be retained by friction in said cup, having a single handle section and a shoulder on said holder adapted to press against and be in contact with said retaining sheet, each said holder having a groove therein forming a gas vent between said sheet and said holder, and `a circumferential ridge to bear against the cylindrical wall of the cup, and reduce inser- If molding tolerances are small, a separate 'tion :and removal friction, plate supporting arms on the end of said fholder away yfrom the handle section, a thin `imetal injection plate between and held by said arms, yand supported against flexure by `the end of said plastic holder, and integral prongs `on said plate extending away from the handle section, forming injection points, and ,a ybiologic on said prongs, adjacent said points.

2. A multiple disposable intracutaneous injector pack- .age comprising: a retaining sheet, a plurality of circular 'cups formed therein, and in each of such oups, a separate 'one-piece plastic holder of rounded configuration and :substantially circular cross section adapted to iit in and `be retained by friction in `said cup, having an approxiimately circular cylindrical handle section and a shoulder on said holder adapted to press against and be in contact with said retaining sheet, said holder having a groove -therein for-ming a gas vent between said sheet and each :said holder, plate supporting arms on the end of said holder away from the handle section, a one-piece metal injector plate between and held by said arms, the principal portion of said plate being at and supported by vthe end of the holder and integral prongs on said plate extending away from the handle section, forming injection points, and a biologic on said prongs, adjacent said points.

3. A multiple disposable intracutaneous injector pack- :age comprising: a retaining sheet, a plurality of circular cups formed therein, and in each of such cups, a onepiece plastic holder of rounded substantially circular cylindrical configuration throughout adapted to tit in and be retained by friction in said cup, having a single handle section and la shoulder on said holder adapted to press against and be in contact with `said retaining sheet, :a gas vent between said sheet land said holder, plate supporting arms on the end of said holder away from the handle section, a metal injector plate the principal portion of said plate being ilat yand supported by the end of the holder between and held by said arms, and prongs on :said plate integral therewith and extending away from the handle section, fonming injection points.

References Cited in the file of this patent UNITED STATES PATENTS 585,007 Rambaud June 22, 1897 616,042 Walsh Dec. 13, 1898 656,914 waish Aug. 2s, 1900 1,489,558 Timson Apr. 8, 1924 2,522,309 Simon Sept. 12, 1950 2,593,110 Crane et al i Apr. 15, 1952 2,612,162 Barry Sept. 30, 1952 2,619,962 Rosenthal Dec. 2, 1952 2,643,764 Riall .lune 30, 1953 2,666,967 Poitras Jan. 26, 1954 2,860,635 Wilburn Nov. 18, 1958 2,876,774 Kravitz et al. Mar. l0', 1959 3,057,471 Stonehill et al. Oct. 9, 1962 3,072,122 Rosenthal Jan. 8, 1963 FOREIGN PATENTS 846,767 Germany Aug. 18, 1952 79,965 Denmark Oct. 10, 1955 

1. A MULTIPLE DISPOSABLE INTRACUTANEOUS PACKAGE COMPRISING: A RETAINING SHEET, A PLURALITY OF CIRCULAR CYLINDRICAL CUPS FORMED THEREIN, AND IN EACH OF SUCH CUPS, A PLASTIC HOLDER OF ROUNDED CONFIGURATION AND SUBSTANTIALLY CIRCULAR CROSS SECTION ADAPTED TO FIT IN AND BE RETAINED BY FRICTION IN SAID CUP, HAVING A SINGLE HANDLE SECTION AND A SHOULDER ON SAID HOLDER ADAPTED TO PRESS AGAINST AND BE IN CONTACT WITH SAID RETAINING SHEET, EACH SAID HOLDER HAVING A GROOVE THEREIN FORMING, A GAS VENT BETWEEN SAID SHEET AND SAID HOLDER, AND A CIRCUMFERENTIAL RIDGE TO BEAR AGAINST THE CYLINDRICAL WALL OF THE CUP, AND REDUCE INSERTION AND REMOVAL FRICTION, PLATE SUPPORTING ARMS ON THE END OF SAID HOLDER AWAY FROM THE HANDLE SECTION, A THIN METAL INJECTION PLATE BETWEEN AND HELD BY SAID ARMS, AND SUPPORTED AGAINST FLEXURE BY THE END OF SAID PLASTIC HOLDER, AND INTEGRAL PRONGS, ON SAID PLATE EXTENDING AWAY FROM THE HANDLE SECTION, FORMING INJECTION POINTS, AND A BIOLOGIC ON SAID PRONGS, ADJACENT SAID POINTS. 